Approximately 60 million Americans suffer from dry eye conditions. Of these, approximately 10 million Americans have been diagnosed with severe dry eye conditions, e.g., Dry Eye Syndrome or Chronic Dry Eye Disease (CDED), both clinically known as keratoconjuctivitis sicca. CDED is a condition that results from inflammation of the eye as well as inflammation of the tear-producing glands. This inflammation decreases the eyes' ability to produce natural tears, which help protect the eyes from irritation and keep them moisturized and lubricated. People who suffer from CDED often experience constant pain from eye irritation, including a sandy or gritty sensation that, if untreated, can lead to scarring or ulceration of the cornea, which can lead to a partial or total loss of vision.
Most cases of CDED result from normal aging of the eye; however, CDED or dry, irritated, tired eyes can occur at any age. It is estimated that nearly 75% of people over the age of 65 will experience CDED conditions. CDED occurs in both men and women; however, it is most common in women who are post-menopausal or pregnant. Approximately 4 million Americans, of which approximately 90% are women, have CDED as a consequence of Sjogren's syndrome, which is a chronic, slowly progressive autoimmune disease characterized by dryness of the eyes and mouth and recurrent salivary enlargement. Other diseases, such as rheumatoid arthritis, lupus, scleroderma, and thyroid disease, can also cause CDED. In addition, health, environmental, and lifestyle conditions can also cause CDED. For example, people suffering from allergies (approximately 50 million people) and people who wear contact lenses (approximately 38 million Americans), have a greater risk of developing CDED. Other circumstances that significantly dry, irritate, and fatigue the eye include: computer use; low humidity environments, such as flying in an airplane, in which the relative humidity is typically between 5% to 15%; certain medications; eye surgery; and certain medical conditions, such as bletharitis (inflammation of the eyelids).
Some early signs of CDED include: 1) an occasional burning sensation in the eyes when a person is in an area of low humidity or high pollution; 2) a persistent and painful gritty sensation in the eyes; 3) an inability to cry under emotional stress; 4) decreased tolerance of contact lenses; and 5) in extreme cases, unusual sensitivity to light, severe eye pain, or diminished vision. In the early stages of the disorder, these symptoms may come and go, but become more persistent as the condition worsens. For most CDED cases, patients experience a greater discomfort as the day-progresses.
Over 25,000 people a day turn 50 years old in the U.S. alone. It is estimated that by 2010, over 140,000,000 Americans will be over the age of 50. As mentioned above, if dry eye conditions are left untreated a person may develop CDED and, eventually, a loss of vision. Thus, with a significant portion of the population aging, the incidence of dry eyes will increase significantly, as will the risk of developing CDED.
The hydration process of eyes and, in particular, the corneal epithelium, includes tear production, evaporation, and outflow loss. Indeed, studies suggest that dry eye conditions are associated with an increased evaporation of tears from the ocular surface. Further, increased humidity around the eye significantly reduces, if not stops, the evaporation of tears and can restore and thicken the lipid layer. See William D. Mathers, M. D., et al., “Tear Flow and Evaporation in Patients with and without Dry Eye”, Ophthalmology, Vol. 103, no. 4 (April 1996), pp. 664-669; William D. Mathers, M. D., “Ocular Evaporation in Meibomian Gland Dysfunction and Dry Eye”, Ophthalmology, Vol. 100, no. 3 (March 1993), pp. 347-351; Donald R. Korb, O. D., et al., “Effect of Periocular Humidity on the Tear Film Lipid Layer”, Cornea, Vol. 15, no. 2 (1996), pp. 129-134.
Presently there is no cure for CDED; however, there exist various treatments that are designed to alleviate the often debilitating pain and discomfort caused by dry eye conditions. Such treatments include artificial tear solutions, moisture chamber glasses, and punctal occlusion.
The most common treatment for people with dry, irritated, or tired eyes is artificial tear solutions, both prescription and over-the-counter eye drops. Artificial tear solutions may or may not contain preservatives. The preservatives used in artificial tear solutions have little or no toxicity; however, artificial tear solutions with preservatives can cause irritation if used frequently. In fact, artificial tear solutions with preservatives are not recommended for frequent use. CDED patients typically need to frequently apply artificial tears, which prohibits the use of artificial tears with preservatives. Preservative-free solutions are available; however, they are expensive and prone to bacterial contamination. While artificial tears primarily increase the comfort of people suffering from dry, irritated eyes, when used frequently they may rinse away the natural tears necessary to reestablish a normal tear film. Frequent use of artificial tears is also expensive; individuals suffering from CDED can spend approximately $300 a year on artificial tears.
Another treatment for dry, irritated eyes is ointments. Typically used for nighttime relief, ointments often blur vision, are messy, awkward to apply, and often do not provide an effective treatment.
Another treatment includes the use of moisture chamber glasses. Moisture chamber glasses are custom-made products designed to alleviate the pain and discomfort caused by dry eye conditions. There are no commercially available moisture chamber glasses; they must be custom fit by an optician and can be prohibitively expensive for the average consumer. Studies have suggested that conventional swim goggles may also be helpful in preserving moisture in dry eyes, as well as protecting eyes from exposure to air currents, such as air conditioning and wind gusts. See, e.g., Donald R. Korb, O. D., et al., “Effect of Periocular Humidity on the Tear Film Lipid Layer”, Cornea, Vol. 15, no. 2 (1996), pp. 129-134. However, conventional swim goggles are not designed for prolonged use and can be uncomfortable to the wearer. Although conventional swim goggles are well designed for the intended use of swimming, the application of conventional swim goggles as a moisture chamber has numerous drawbacks, including: 1) the optics and field of view are designed for swimming; 2) conventional swim goggles typically have a narrow orbital seal that is designed to keep water out and which is located inside the orbital bone and supported by the sensitive inner ocular area; 3) the straps are designed for short-term wear, under tension, and are not designed for sleeping; 4) the lens and body design is manufactured of a polycarbonate rigid plastic, which is inherently uncomfortable because of its rigid nature and because the exterior contour creates pressure on the eye socket when the wearer is laying down; 5) conventional swim goggles encompass a smaller surface area around the eye, thereby reducing the potential to trap moisture and heat from the skin surrounding the eye; 6) conventional swim goggle designs tend to cut off capillary blood vessels of the skin in the area surrounding the eyes; 7) conventional swim goggle lenses are typically treated with an anti-fog coating, which is either hydrophobic, hydrophilic, or a blend of the two, and which can cause irritation to the eyes.
Punctal occlusion, the closure of the tear ducts, is another type of treatment for dry eyes that can provide an increased volume of tears remaining in the eye area by decreasing drainage. Under this method of treatment, the lower puncta, which carry away the majority of tears, are sealed using a collagen or silicone plug, or by surgery, via electrocautery or an argon laser. Plugging is typically done for evaluation purposes or when the sufferer's dry eye conditions vary in severity. A collagen plug lasts only a short time, may not occlude completely, and is eventually absorbed. The silicone plug is not absorbed, but can easily be removed. Surgical occlusion is a permanent treatment option for dry eye sufferers; however, surgery may have to be repeated because the puncta tend to reopen. Punctal occlusion can be an expensive treatment for dry eye conditions, ranging in price from $500 to $650.
Thus, a need exists for an apparatus, system and method for treating dry eye and/or irritated eye conditions that is natural, easy to use, comfortable and safe to the wearer, inexpensive, and which provides therapeutic benefits for the eyes without the discomfort, invasiveness, and limited use of the currently available treatments. A need also exists for an apparatus, system and method that can be used to promote healthy eyes and can reduce the possibility of developing CDED by improving the health of the lipid layer. Further, there is an unmet need for such an apparatus and method that allows for removably engageable components to facilitate customization of moisture and/or medicinal treatment, sanitary use by one or multiple users, and communication of moisture and/or medicine to each respective eye of the user.